Identity
- Trade Name
- SpectoMED FDA UDI
- Generic Name
- Multidisciplinary medical image management software FDA UDI
- Device Name
- SpectoMED EUDAMEDSpectoMed provides real-time spatial-visualization of medical imaging allowing the manipulation, processing, review, analysis, communication and media interchange of multi-dimensional digital images of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient’s anatomy as well as their intraoperative display. SpectoMed is intended as an aid for assessing patient images. FDA UDI
- Model / Reference
- 01 EUDAMEDV1 FDA UDI
- Description
- SpectoMed provides real-time spatial-visualization of medical imaging allowing the manipulation, processing, review, analysis, communication and media interchange of multi-dimensional digital images of several modalities as defined by the DICOM standard, such as CT or MRI imaging datasets. Furthermore, SpectoMed aids the clinician in the preparation of a surgical intervention with measurements and import of compatible objects within the realistic spatial visuals of the patient’s anatomy as well as their intraoperative display. SpectoMed is intended as an aid for assessing patient images. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07649998031011 EUDAMEDFDA UDI
- Basic UDI-DI
- 7649998031SPECTOMEDQG EUDAMED
- 510(k) Number
- K242205 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Multidisciplinary medical image management software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
SpectoMED by Specto Medical AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7649998031SPECTOMEDQG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Specto Medical AG
- EUDAMED SRN
- CH-MF-000042032
- Authorised Representative
- MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211
Sources (2)
- EUDAMED 24ce5dfd-6a2a-4f5b-8980-7e0b55a87712 61 fields · synced Jul 10, 2026
- FDA UDI 56ce59ba-3e7f-4555-a05f-282d2dd9b2df 34 fields · synced May 30, 2026